The following data is part of a premarket notification filed by Voco Gmbh with the FDA for Grandio So.
| Device ID | K102351 |
| 510k Number | K102351 |
| Device Name: | GRANDIO SO |
| Classification | Material, Tooth Shade, Resin |
| Applicant | VOCO GMBH ANTON-FLETTNER-STRASSE 1-3 Cuxhaven, DE D-27472 |
| Contact | Manfield T Plaumann |
| Correspondent | Manfield T Plaumann VOCO GMBH ANTON-FLETTNER-STRASSE 1-3 Cuxhaven, DE D-27472 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-08-19 |
| Decision Date | 2010-11-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E22126481 | K102351 | 000 |
| E22126351 | K102351 | 000 |
| E22126331 | K102351 | 000 |
| E22126311 | K102351 | 000 |
| E22126301 | K102351 | 000 |
| E22126291 | K102351 | 000 |
| E22126271 | K102351 | 000 |
| E22126241 | K102351 | 000 |
| E22126211 | K102351 | 000 |
| E22126201 | K102351 | 000 |
| E22126191 | K102351 | 000 |
| E22126161 | K102351 | 000 |
| E22126151 | K102351 | 000 |
| E22126141 | K102351 | 000 |
| E22126131 | K102351 | 000 |
| E22126121 | K102351 | 000 |
| E22126111 | K102351 | 000 |
| E22126101 | K102351 | 000 |
| E22126401 | K102351 | 000 |
| E22126461 | K102351 | 000 |
| E22126751 | K102351 | 000 |
| E22126731 | K102351 | 000 |
| E22126711 | K102351 | 000 |
| E22126701 | K102351 | 000 |
| E22126691 | K102351 | 000 |
| E22126671 | K102351 | 000 |
| E22126641 | K102351 | 000 |
| E22126611 | K102351 | 000 |
| E22126601 | K102351 | 000 |
| E22126591 | K102351 | 000 |
| E22126561 | K102351 | 000 |
| E22126551 | K102351 | 000 |
| E22126541 | K102351 | 000 |
| E22126531 | K102351 | 000 |
| E22126521 | K102351 | 000 |
| E22126511 | K102351 | 000 |
| E22126501 | K102351 | 000 |
| E22126001 | K102351 | 000 |